Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path." FDA is issuing this guidance to inform industry and agency staff of steps that are needed to ensure the safe and effective use of in vitro diagnostic (IVD) devices intended for use in the detection of influenza A (or A/B) virus directly from human specimens. FDA is taking this action because of recent significant public health concerns associated with emergence of an avian influenza A virus strain as a human pathogen in Southeast Asia. This guidance document describes recommendations for fulfilling labeling requirements applicable to all IVDs intended to generally detect influenza A (or A/B) virus directly from human specimens, and outlines the premarket regulatory path for new or modified devices intended to generally detect influenza A virus, or to detect and differentiate, specific novel influenza A viruses infecting humans. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices.